November 10, 2015
FDA Advisory Committee Recommends Approval of Sugammadex to Reverse Neuromuscular Blockade
On Friday, November 6, the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee voted in favor of the FDA approving sugammadex for the proposed indication of reversal of moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Prior to the meeting, the American Society of Anesthesiologists (ASA) submitted a letter to the FDA Advisory Committee stating that “there is a real need for a novel, unique drug to provide physician anesthesiologists with better capabilities to reverse NMB induced by rocuronium or vecuronium,” and that “it would significantly enhance the ability of physician anesthesiologists to more safely care for patients and reduce the incidence of critical respiratory adverse events in the PACU, especially for patients most at risk.”
This FDA Committee meeting is the latest step in the regulatory process since Organon USA, Inc. originally submitted the new drug application for sugammadex to the FDA in 2007. The Committee’s recommendation is not binding, and the FDA will take it into consideration as it determines whether to approve the drug.
ASA will continue to monitor FDA action on sugammadex and other medications that fill this important clinical need.